Integration of control and business information technologies are opening new windows
of enterprise transparency

As with any contemporary, complex manufacturing enterprise, information technology (IT) is a key, critical element crucial to effective and efficient operations. This is especially true for Pharma and Life Sciences. Of course it is, just ask any traditional IT operative in your organization; they’re sure to tell you the whole place would come to a screeching halt without their expert guidance and technology. Pride aside, it’s more or less fact. The digital age has introduced much in the way of game-changing technology to the “business” side of the house, including fundamental protocols, pervasive enterprise resource planning (ERP) platforms, and all those familiar, perennial business applications. Further, the exigencies of business operations demanded ever-more massive data-handling infrastructures, which is now outsourced and the engine that drove the rise of the cloud.

What are IQ, OQ and PQ, and Why are They Required in the Pharmaceutical Industry?

These acronyms identify common terms that you’ll see in many FDA and Health Canada guidance documents. Learn what they are and why they are important in this blog post from the experts at Wellspring Pharma Services.

Manufacturing engineers also embraced the computer age and within just a few decades industry embraced the notion of computer-integrated manufacturing (CIM) and transformed its myriad analog, hard-wired and manual control systems into a networked ecosystem of operational technologies (OT), that is, distributed digital control networks, automation and sensing to help better understand manufacturing and processing operations. It was only natural to begin to see the possibilities of connecting all the data and information coming from these rich fields. In a recent Smart Industry magazine editorial, Peter Martin, president of Schneider Electric related this bit about the rise of CIM in the 1980s: “We had the idea that if we took networks and tied all the computers we had together, something good was bound to happen.”

That was the vision, but Martin’s comment reveals much because it captures the magical thinking that (at the time) accompanied this technological innovation. Colleague and veteran industry observer Keith Larson, editor of sister publication Smart Industry explained that in spite of good intentions, at the outset “Integration was hard; integration was time-consuming; integration was expensive. And, once achieved, these custom links were brittle and maintenance-intensive too. As a result, only those integration projects deemed essential to operations or those that cleared a very high return on investment bar were undertaken — and only then by the enterprises with the resources to fund them.”

The dream became more a waking nightmare to some; integration and communication across domains was difficult at best and those who embarked on this path found that the initial investment was only one element of an increasingly expensive proposition that consumed operational resources and budgets, ultimately putting extreme pressure on its overall value proposition.

Networking production assets, monitoring critical and operating state process, and generally getting data flowing across manufacturing operations was hard enough, and the notion of deriving business value by integrating and sharing this data with the business systems and analytical platforms in the C-suite really did seam like magical thinking, and kept the two “technocracies” if you will, entrenched in their respective kingdoms, managing an uneasy detente.

CONVERGENCEFor many a year, IT and OT disciplines ran along parallel tracks, introducing advancements and features that served the interests of their respective groups. Few in either camp were focused on delivering the potential of these technologies beyond their traditional roles; even after some 35 years the industry is still talking about the divide. But the gap is closing, and judging by the high level alliances between titans like Cisco, SAP, Oracle IBM and automation giants like Emerson, Rockwell, Siemens, Werum and others, OT and IT convergence is their collective solution to managing the incredible complexities associated with the global pharmaceutical manufacturing enterprise, and the cloud is where they all are convinced this utopia can be realized.

In 2015 the technical and economic barriers to OT/IT convergence are falling away, creating much stronger, more robust, reliable links. Perhaps most important has been the increasing amount of computing power end devices like sensors and controllers have built in — in other words, the availability of increasingly “smart” controlling and sensing technologies with that are capable of crunching incredible volumes of data at the edge of plant networks. Similarly, the industry developed open integration and communication standards that have dramatically improved the efficacy of the links demanded of real-time highly integrated OT networks.

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